Dangerous drug lawyers at Pintas & Mullins Law Firm announce that the U.S. Department of Health and Human Services recently subpoenaed Johnson & Johnson subsidiary, Janssen Pharmaceuticals, over the safety and marketing of its drug Nucynta.
The Department of Health is generally responsible for investigating any possible incidents of fraud, abuse or waste of federal funds such as Medicare and Medicaid, which pays for prescription drugs if the beneficiary requires it. Nucynta (generic tapentadol) is a narcotic painkiller used to treat moderate to severe short-term pain.
Warnings associated with Nucynta are similar to any other opiate-type pharmaceutical, having a high risk of abuse and severe, potentially fatal breathing problems. The subpoena was filed in seeking of company documents and information about the sales, marketing and promotional materials regarding Nucynta. The federal agency is also seeking any and all related studies, reports, and complaints regarding the medication, particularly of its side effects and safety.
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Tellingly, the subpoena seeks the detailed numbers and account information of the physicians and health-care providers who are on Janssen’s payroll. In 2012, the FDA established new safety measures as part of a risk-management plan for specific opioids, including Nucynta, which requires manufacturers to train physicians on their payroll now to properly prescribe the drugs. This effort was taken after sharp increases in overdoses and abuse.
The FDA first approved Nucynta in 2008; in 2011, the extended-release tablets were put on market, and the approved uses expanded from relief of acute pain in adults to management of neuropathic pain in diabetics as well. Financial experts estimate that Nucynta will give Janssen Pharmaceuticals a yearly sale of $230 million in 2013.
The process of getting drugs approved is incredibly long, intricate and expensive, as manufacturers must prove through third-party studies and clinical trials that a certain drug is safe and effective to treat certain, specific ailments. For that reason, drugs are usually only able to be sold and marketed for treatment of one type of ailment, such as chronic pain, though it may be useful in other ways as well.
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If the company is large enough – and Johnson & Johnson certainly is – they often simply ignore federal guidelines and market drugs to physicians and patients for other uses than what the drug was approved for. One notable example of this would be the years-long investigation into the marketing of Risperdal, which ultimately led to a $2 billion settlement with Johnson & Johnson.
In July 2013, pharmaceutical giant Novartis was asked by the U.S. Attorney’s office to disclose information about Gilenya, its drug to treat multiple sclerosis. That request also sought records on payments to doctors and marketing practices. A month prior, Forest Laboratories was issued a subpoena that requested information about the marketing of its new lung treatment Tudorza Pressair.
Another notable example of federal investigations leading to large payouts by manufacturers is the $490 million settlement by Pfizer over its illegal marketing of Rapamune, a kidney transplant drug. Pfizer recently acquired Wyeth Pharmaceuticals, which trained its sales representatives and managers to openly discuss unapproved, off-label uses for Rapamune with doctors. Wyeth also paid speaks to hype the drug’s benefits at physician meetings.
Big-pharma companies like Novartis and Johnson & Johnson can afford to pay the fines for marketing the drug illegally, and have incentive to do so, evidenced by the fact that 90% of Rapamune’s sales were generated by unapproved uses in 2006.This is done, however, at the expense of patient health and safety. Americans are unknowingly being prescribed drugs that are not only not been tested for safety, but may be ineffective for their condition as well, and expose them to an array of dangerous, life-threatening side effects.
Nucynta lawyers at Pintas & Mullins Law Firm have decades of experience working with clients seriously injured by defective and dangerous drugs. If you believe your injuries were caused by a defectively designed or produced medication, you may be entitled to significant compensation through a lawsuit against the manufacturer.